Label: SANTOTIZER- hand santizer solution liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 29, 2021

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  • Alcohol 80% v/v

    1.3oz3600 ml label

  • DOSAGE & ADMINISTRATION

    Directions

    Place enough product on hands to cover all surfaces. Rub hands together until dry.
    Supervise children under 6 years of age when using this product to avoid swallowing.

  • WARNINGS

    Warnings

    For external use only. Flammable. Keep away from heat or flame.

  • INACTIVE INGREDIENT

    Inactive ingredients glycerin, hydrogen peroxide, purified water

  • INDICATIONS & USAGE

    Use[s]

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • PURPOSE

    Purpose

    Antiseptic

  • PRINCIPAL DISPLAY PANEL

    3,600ml NDC 73976-1330-1

    18,000ml NDC 73976-1330-2

    200,000ml NDC 73976-1330-3

    1,022,000ml NDC 73976-1330-4 3600ml 18000ml200000ml1022000ml

  • INGREDIENTS AND APPEARANCE
    SANTOTIZER 
    hand santizer solution liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73976-1330
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 L  in 100 L
    Inactive Ingredients
    Ingredient NameStrength
    HYDROGEN PEROXIDE (UNII: BBX060AN9V) 0.125 L  in 100 L
    WATER (UNII: 059QF0KO0R) 18.4 L  in 100 L
    GLYCERIN (UNII: PDC6A3C0OX) 1.45 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73976-1330-3200 L in 1 DRUM; Type 0: Not a Combination Product03/30/2020
    2NDC:73976-1330-13.6 L in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    3NDC:73976-1330-218 L in 1 PAIL; Type 0: Not a Combination Product03/30/2020
    4NDC:73976-1330-41022 L in 1 TANK; Type 0: Not a Combination Product03/30/2020
    5NDC:73976-1330-60.0384456 L in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/16/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/30/2020
    Labeler - Santolubes LLC (144734980)
    Registrant - Santolubes LLC (144734980)
    Establishment
    NameAddressID/FEIBusiness Operations
    Santolubes LLC144734980manufacture(73976-1330)
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